Form 8-K

8-K — Zura Bio Ltd

Accession: 0001104659-26-124149

Filed: 2026-11-09

Period: 2026-11-09

CIK: 0001855644

SIC: 2836 (BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES))

Item: Other Events

Item: Financial Statements and Exhibits

Documents

8-K — tm2629310d1_8k.htm (Primary)

EX-99.1 — EXHIBIT 99.1 (tm2629310d1_ex99-1.htm)

XML — IDEA: XBRL DOCUMENT (R1.htm)

8-K — FORM 8-K

8-K (Primary)

Filename: tm2629310d1_8k.htm · Sequence: 1

false

0001855644

2026-11-09

iso4217:USD

xbrli:shares

iso4217:USD

xbrli:shares

Warrants [Member]

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington,

D.C. 20549

Form

8-K

Current

Report

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event

reported): November 9, 2026

ZURA BIO LIMITED

(Exact name of Registrant as specified in its charter)

Cayman Islands

001-40598

98-1725736

(State or other jurisdiction of

incorporation)

(Commission

File Number)

(I.R.S. Employer

Identification No.)

1489 W. Warm Springs Rd. #110

Henderson, NV 89014

(Address of principal

executive offices,

including zip code)

(702) 825-9872

(Registrant’s telephone

number, including area code)

N/A

(Former name or former address,

if changed since last report)

Check the appropriate box below if the Form 8-K is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

¨ Written

communications pursuant to Rule 425 under the Securities Act

¨ Soliciting

material pursuant to Rule 14a-12 under the Exchange Act

¨ Pre-commencement

communications pursuant to Rule 14d-2(b) under the Exchange Act

¨ Pre-commencement

communications pursuant to Rule 13e-4(c) under the Exchange Act

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading Symbol(s)

Name

of each exchange on which

registered

Class A Ordinary Shares, par value $0.0001 per share

ZURA

The

Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth

company as defined in Rule 405 of the Securities Act of 1933 (§230A05 of this chapter) or Rule 12b-2 of the Securities Exchange Act

of 1934 (§240.12b-2 of this chapter).

Emerging growth company x

If an emerging growth company, indicate by check mark if the registrant

has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant

to Section 13(a) of the Exchange Act. ¨

Item 8.01. Other Events.

On November 9, 2026, Zura Bio Limited, a Cayman

Islands exempted company (the “Company”), issued a press release providing a clinical update on the Company’s Phase

2 TibuSHIELD study of tibulizumab (ZB-106) in adults with moderate-to-severe hidradenitis suppurativa. A copy of the press release is

attached hereto as Exhibit 99.1 and is incorporated herein by reference.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits.

Exhibit No.

Description

99.1

Press release, dated November 9, 2026

104

Cover Page Interactive Data File (embedded within the Inline XBRL document).

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934,

the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Date: November 9, 2026

ZURA BIO LIMITED

By:

/s/ Sandeep Kulkarni

Name:

Sandeep Kulkarni

Title:

Chief Executive Officer

EX-99.1 — EXHIBIT 99.1

EX-99.1

Filename: tm2629310d1_ex99-1.htm · Sequence: 2

Exhibit 99.1

Zura Bio Provides Clinical Update

on Phase 2 TibuSHIELD Study of Tibulizumab (ZB-106) in Hidradenitis Suppurativa

November 9, 2026 7:00 AM

· Study

did not meet primary endpoint of percentage change from baseline in total abscess and inflammatory

nodule (AN) count at Week 16

· Key

secondary endpoints, including HiSCR50 and HiSCR75, were not met

· Both

doses of tibulizumab were well tolerated; observed safety was consistent with established

safety profiles for both IL-17 and BAFF inhibition

· The

ongoing TibuSURE trial in systemic sclerosis (SSc) and the planned NEXUS-PMR trial in polymyalgia

rheumatica (PMR) will continue, with data expected in H1 2027 and Q4 2028, respectively;

Zura is discontinuing development in hidradenitis suppurativa

HENDERSON, Nev.--(BUSINESS WIRE)--November

9, 2026-- Zura Bio Limited (Nasdaq: ZURA) (“Zura”), a clinical-stage biotechnology company developing novel and differentiated

medicines to meaningfully improve the lives of patients with serious and debilitating autoimmune and inflammatory diseases, today announced

that its Phase 2 TibuSHIELD study, which evaluated tibulizumab (ZB-106) in adults with moderate-to-severe hidradenitis suppurativa (HS),

did not meet its primary endpoint of percentage change from baseline in total abscess and inflammatory nodule (AN) count at Week 16 in

either the 300 mg or 150 mg treatment arm. Key secondary endpoints, including HiSCR50 and HiSCR75, were also not met.

TibuSHIELD was a global, randomized,

double-blind, placebo-controlled Phase 2 trial evaluating the safety, tolerability, and efficacy of tibulizumab in adults with moderate-to-severe

HS. The trial enrolled 247 participants randomized 1:1:1 to receive one of two tibulizumab dose regimens or placebo. The study included

a 16-week efficacy assessment period, followed by an optional 16-week open-label extension (OLE), with a 12-week safety follow-up period.

At Week 16, study participants experienced

56.0% and 58.1% reductions from baseline in AN count in the tibulizumab 300 mg and 150 mg arms, respectively, compared with a 52.5% reduction

in the placebo arm. HiSCR50 response rates were 48.0% and 52.7% for the tibulizumab 300 mg and 150 mg arms, respectively, versus 45.5%

for placebo. HiSCR75 response rates were 35.3% and 34.0% for the tibulizumab 300 mg and 150 mg arms, respectively, versus 28.1% for placebo.

Results are shown in Table 1 below.

“We are disappointed to report

that the TibuSHIELD study was unable to deliver a positive outcome for patients. Despite TibuSHIELD being a large and well-controlled

study, these results highlight the challenges of developing medicines in hidradenitis suppurativa, including the high variability of

placebo responses. We are conducting a full analysis of the data to understand what it tells us about the biology of HS, the impact of

tibulizumab, and the roles of IL-17 and BAFF. We are grateful to the patients, caregivers, and investigators whose participation and

commitment made this study possible,” said Sandeep Kulkarni, MD, Chief Executive Officer of Zura. “We remain committed to

exploring the effect of dual IL-17 and BAFF inhibition in SSc and PMR, two indications with distinct and uncorrelated pathobiologies

and clinical presentations from those of HS. We are looking forward to reporting topline results from our TibuSURE study in systemic

sclerosis in the first half of 2027 and starting the NEXUS-PMR study by the end of this year.”

Based on these results, Zura is discontinuing

development of tibulizumab in HS. Additional analyses are ongoing, including pharmacokinetic/pharmacodynamic assessments, exposure-response

relationships, and the impact of HS-specific factors. Zura continues to advance tibulizumab in SSc and PMR, which have biology distinct

from HS. Hidradenitis suppurativa is a deep-tissue disease in which the pharmacology of biologic therapies is known to differ from that

in systemic autoimmune conditions. Systemic sclerosis and polymyalgia rheumatica are driven by distinct immune mechanisms, in which B-cell

and IL-17 pathways are each independently implicated.

Table 1: Results on key efficacy

endpoints

Endpoint, Week 16

Tibulizumab 300 mg

(N=82)

Tibulizumab 150 mg

(N=82)

Placebo (N=82)

% change in AN count (primary)

56.0

58.1

52.5

HiSCR50, %

48.0

52.7

45.5

HiSCR75, %

35.3

34.0

28.1

Discontinuation rate, %

11.0

12.2

14.6

% change in AN count = reductions

from baseline in total abscess and inflammatory nodule (AN) count.

HiSCR50 = ≥50% reduction from

baseline in total abscess and inflammatory nodule count, with no increase in abscess or draining tunnel count.

HiSCR75 = ≥75% reduction from

baseline in total abscess and inflammatory nodule count, with no increase in abscess or draining tunnel count.

For HiSCR50 and HiSCR75,

missing data and intercurrent events were handled by modified non-responder imputation (mNRI).

Table 2: Safety up to Week 16 –

adverse events

Tibulizumab 300 mg

(N=82)

Tibulizumab 150 mg

(N=82)

Placebo (N=82)

Any treatment-emergent adverse events (TEAEs)

43 (52.4%)

38 (46.3%)

Treatment-emergent serious AEs

5 (6.1%)

3 (3.7%)

1 (1.2%)

Treatment-related serious AEs

1 (1.2%)

TEAEs leading to discontinuation of study treatment

2 (2.4%)

3 (3.7%)

2 (2.4%)

The data show that tibulizumab was well

tolerated and observed safety was consistent with established safety profiles for both IL-17 and BAFF inhibition. One death (cardiac

arrest in a participant with multiple cardiovascular risk factors) was reported in the 300 mg tibulizumab arm during the study and was

determined by the site investigator to be unrelated to study treatment. There was one adverse event of special interest (AESI): an exacerbation

of pre-existing inflammatory bowel disease in a participant randomized to the 300 mg tibulizumab arm.

Anticipated upcoming milestones

The Company remains committed to the

ongoing TibuSURE study of tibulizumab in systemic sclerosis, with topline data expected in H1 2027, and to the planned NEXUS-PMR study

in polymyalgia rheumatica, with data expected in Q4 2028.

As of September 30, 2026, Zura had cash

and cash equivalents of $187.7 million. Zura expects that its existing cash and cash equivalents are sufficient to support planned operations

through at least the end of 2028.

About Zura

Zura is a clinical-stage, multi-asset

immunology company developing novel dual-pathway antibodies for autoimmune and inflammatory diseases with unmet need. Zura’s pipeline

includes product candidates designed to target key mechanisms of immune system imbalance, with the goal of improving efficacy, safety,

and dosing convenience for patients.

Zura’s lead product candidate,

tibulizumab (ZB-106), is being evaluated in TibuSURE, a Phase 2 study in systemic sclerosis (SSc). NEXUS-PMR, a Phase 2 study in polymyalgia

rheumatica (PMR), is planned to be initiated by year-end 2026. Additional product candidates torudokimab (ZB-880) and crebankitug (ZB-168)

have completed Phase 1/1b studies and are being evaluated for their potential across a range of autoimmune and inflammatory conditions.

For more information, please visit www.zurabio.com.

About Tibulizumab

Tibulizumab is a bispecific dual-antagonist

antibody engineered by the fusion of tabalumab with a single-chain variable fragment (scFv) derived from ixekizumab (Taltz®). Tibulizumab

is designed to neutralize interleukin-17 and B-cell activating factor. It is being evaluated in Phase 2 clinical studies in adults with

systemic sclerosis and hidradenitis suppurativa, with a Phase 2 study in PMR planned to be initiated by the end of 2026. Before Zura

in-licensed tibulizumab, Lilly conducted Phase 1/1b studies in patients with Sjögren’s syndrome and rheumatoid arthritis.

Tibulizumab is an investigational compound

and has not been approved for marketing by the U.S. Food and Drug Administration (FDA) or any other regulatory authority.

FORWARD-LOOKING

STATEMENTS

Any statements contained in this press

release that do not describe historical facts may constitute “forward-looking statements” as that term is defined in the

Private Securities Litigation Reform Act of 1995. These statements may be identified by words and phrases such as “anticipate,”

“believe,” “continue,” “could,” “designed to,” “expect,” “goal,”

“intend,” “may,” “outlook,” “plan,” “potential,” “should,” “will,”

and similar expressions, and are based on Zura’s current beliefs and expectations. These forward-looking statements include, but

are not limited to, statements regarding the development and potential therapeutic benefits of Zura’s product candidates; the initiation,

timing, progress, design and results of Zura’s current and future clinical trials, including the reporting of data therefrom; the

sufficiency of Zura’s cash resources and projected cash runway; and other statements that are not historical facts. These statements

involve risks and uncertainties that could cause actual results to differ materially from those reflected in such forward-looking statements.

Risks and uncertainties that may cause actual results to differ materially include, but are not limited to: uncertainties inherent in

the development of therapeutic product candidates, such as the risk that one or more of Zura’s current or future product candidates

may not be successfully developed or commercialized; the risk of delay or cessation of any planned or ongoing clinical trials of Zura’s

current or future product candidates; the risk that prior results, including signals of safety, activity or durability of effect observed

in preclinical studies or clinical trials, may not be replicated or may not continue in ongoing or future studies or clinical trials;

the risk that modeling data indicating therapeutic potential, or clinical evidence from other drug candidates, may not be predictive

of results in Zura’s current or future clinical trials; the risk that Zura’s product candidates or procedures in connection

with their administration may not have the safety or efficacy profiles anticipated; risks related to the accuracy of Zura’s estimates

of expenses, capital requirements and needs for additional financing; changes in expected or existing competition; changes in the regulatory

environment; uncertainties related to the timing and outcome of the regulatory approval process; unexpected litigation or other disputes;

the impact of macroeconomic conditions on Zura’s business, clinical trials and financial position; and other risks and uncertainties

described in Zura’s Annual Report on Form 10-K for the year ended December 31, 2025, and other filings with the Securities and

Exchange Commission. Any forward-looking statements speak only as of the date of this press release and are based on information available

to Zura as of the date hereof. Zura assumes no obligation to, and does not intend to, update any forward-looking statements, whether

as a result of new information, future events or otherwise, except as required by law.

CONTACTS

Investor and media

inquiries:

ir@zurabio.com

XML — IDEA: XBRL DOCUMENT

XML

Filename: R1.htm · Sequence: 7

v3.26.3

Cover

Nov. 09, 2026

Cover [Abstract]

Document Type

8-K

Amendment Flag

false

Document Period End Date

Nov. 09, 2026

Entity File Number

001-40598

Entity Registrant Name

ZURA BIO LIMITED

Entity Central Index Key

0001855644

Entity Tax Identification Number

98-1725736

Entity Incorporation, State or Country Code

Entity Address, Address Line One

1489 W. Warm Springs Rd.

Entity Address, Address Line Two

#110

Entity Address, City or Town

Henderson

Entity Address, State or Province

Entity Address, Postal Zip Code

89014

City Area Code

702

Local Phone Number

825-9872

Written Communications

false

Soliciting Material

false

Pre-commencement Tender Offer

false

Pre-commencement Issuer Tender Offer

false

Title of 12(b) Security

Class A Ordinary Shares, par value $0.0001 per share

Trading Symbol

ZURA

Security Exchange Name

NASDAQ

Entity Emerging Growth Company

true

Elected Not To Use the Extended Transition Period

false

- Definition

Boolean flag that is true when the XBRL content amends previously-filed or accepted submission.

+ References

No definition available.

+ Details

Name:

dei_AmendmentFlag

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration

- Definition

Area code of city

+ References

No definition available.

+ Details

Name:

dei_CityAreaCode

Namespace Prefix:

dei_

Data Type:

xbrli:normalizedStringItemType

Balance Type:

Period Type:

duration

- Definition

Cover page.

+ References

No definition available.

+ Details

Name:

dei_CoverAbstract

Namespace Prefix:

dei_

Data Type:

xbrli:stringItemType

Balance Type:

Period Type:

duration

- Definition

For the EDGAR submission types of Form 8-K: the date of the report, the date of the earliest event reported; for the EDGAR submission types of Form N-1A: the filing date; for all other submission types: the end of the reporting or transition period. The format of the date is YYYY-MM-DD.

+ References

No definition available.

+ Details

Name:

dei_DocumentPeriodEndDate

Namespace Prefix:

dei_

Data Type:

xbrli:dateItemType

Balance Type:

Period Type:

duration

- Definition

The type of document being provided (such as 10-K, 10-Q, 485BPOS, etc). The document type is limited to the same value as the supporting SEC submission type, or the word 'Other'.

+ References

No definition available.

+ Details

Name:

dei_DocumentType

Namespace Prefix:

dei_

Data Type:

dei:submissionTypeItemType

Balance Type:

Period Type:

duration

- Definition

Address Line 1 such as Attn, Building Name, Street Name

+ References

No definition available.

+ Details

Name:

dei_EntityAddressAddressLine1

Namespace Prefix:

dei_

Data Type:

xbrli:normalizedStringItemType

Balance Type:

Period Type:

duration

- Definition

Address Line 2 such as Street or Suite number

+ References

No definition available.

+ Details

Name:

dei_EntityAddressAddressLine2

Namespace Prefix:

dei_

Data Type:

xbrli:normalizedStringItemType

Balance Type:

Period Type:

duration

- Definition

Name of the City or Town

+ References

No definition available.

+ Details

Name:

dei_EntityAddressCityOrTown

Namespace Prefix:

dei_

Data Type:

xbrli:normalizedStringItemType

Balance Type:

Period Type:

duration

- Definition

Code for the postal or zip code

+ References

No definition available.

+ Details

Name:

dei_EntityAddressPostalZipCode

Namespace Prefix:

dei_

Data Type:

xbrli:normalizedStringItemType

Balance Type:

Period Type:

duration

- Definition

Name of the state or province.

+ References

No definition available.

+ Details

Name:

dei_EntityAddressStateOrProvince

Namespace Prefix:

dei_

Data Type:

dei:stateOrProvinceItemType

Balance Type:

Period Type:

duration

- Definition

A unique 10-digit SEC-issued value to identify entities that have filed disclosures with the SEC. It is commonly abbreviated as CIK.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b-2

+ Details

Name:

dei_EntityCentralIndexKey

Namespace Prefix:

dei_

Data Type:

dei:centralIndexKeyItemType

Balance Type:

Period Type:

duration

- Definition

Indicate if registrant meets the emerging growth company criteria.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b-2

+ Details

Name:

dei_EntityEmergingGrowthCompany

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration

- Definition

Indicate if an emerging growth company has elected not to use the extended transition period for complying with any new or revised financial accounting standards.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Securities Act

-Number 7A

-Section B

-Subsection 2

+ Details

Name:

dei_EntityExTransitionPeriod

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration

- Definition

Commission file number. The field allows up to 17 characters. The prefix may contain 1-3 digits, the sequence number may contain 1-8 digits, the optional suffix may contain 1-4 characters, and the fields are separated with a hyphen.

+ References

No definition available.

+ Details

Name:

dei_EntityFileNumber

Namespace Prefix:

dei_

Data Type:

dei:fileNumberItemType

Balance Type:

Period Type:

duration

- Definition

Two-character EDGAR code representing the state or country of incorporation.

+ References

No definition available.

+ Details

Name:

dei_EntityIncorporationStateCountryCode

Namespace Prefix:

dei_

Data Type:

dei:edgarStateCountryItemType

Balance Type:

Period Type:

duration

- Definition

The exact name of the entity filing the report as specified in its charter, which is required by forms filed with the SEC.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b-2

+ Details

Name:

dei_EntityRegistrantName

Namespace Prefix:

dei_

Data Type:

xbrli:normalizedStringItemType

Balance Type:

Period Type:

duration

- Definition

The Tax Identification Number (TIN), also known as an Employer Identification Number (EIN), is a unique 9-digit value assigned by the IRS.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b-2

+ Details

Name:

dei_EntityTaxIdentificationNumber

Namespace Prefix:

dei_

Data Type:

dei:employerIdItemType

Balance Type:

Period Type:

duration

- Definition

Local phone number for entity.

+ References

No definition available.

+ Details

Name:

dei_LocalPhoneNumber

Namespace Prefix:

dei_

Data Type:

xbrli:normalizedStringItemType

Balance Type:

Period Type:

duration

- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 13e

-Subsection 4c

+ Details

Name:

dei_PreCommencementIssuerTenderOffer

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration

- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 14d

-Subsection 2b

+ Details

Name:

dei_PreCommencementTenderOffer

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration

- Definition

Title of a 12(b) registered security.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b

+ Details

Name:

dei_Security12bTitle

Namespace Prefix:

dei_

Data Type:

dei:securityTitleItemType

Balance Type:

Period Type:

duration

- Definition

Name of the Exchange on which a security is registered.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection d1-1

+ Details

Name:

dei_SecurityExchangeName

Namespace Prefix:

dei_

Data Type:

dei:edgarExchangeCodeItemType

Balance Type:

Period Type:

duration

- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as soliciting material pursuant to Rule 14a-12 under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 14a

-Subsection 12

+ Details

Name:

dei_SolicitingMaterial

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration

- Definition

Trading symbol of an instrument as listed on an exchange.

+ References

No definition available.

+ Details

Name:

dei_TradingSymbol

Namespace Prefix:

dei_

Data Type:

dei:tradingSymbolItemType

Balance Type:

Period Type:

duration

- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Securities Act

-Number 230

-Section 425

+ Details

Name:

dei_WrittenCommunications

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration